Summary:
Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of the laboratory's 2017, 2018, and 2019 Coulter AcT diff 2 calibration records, review of manufacturer's instructions, and interview with the laboratory director 8/8/19, the laboratory failed to perform calibration at least once every six months and failed to follow manufacturer's instructions for performing calibration. Findings: 1. The laboratory's "Coulter AcT Diff 2 Analyzer" procedure (revised 7/11/19) states "... Calibration is required every 6 months. ..." Review of 2017, 2018, and 2019 Coulter AcT diff 2 calibration records revealed calibration was performed 10/11/17, 10/11/18, and 5/1/19, but not every six months as required. During interview at approximately 11:15 a.m., the laboratory director stated that there was a change in service personnel during the time the calibration was due in April 2018, so the calibration must have been overlooked. 2. The Coulter AcT diff 2 Operator's manual includes instructions for performing calibration using S-CAL calibrator in section 5.6 "AUTO-CALIBRATION" beginning on page 5-10. Instructions include examples of the records that should be maintained for each calibration, and instructions on page 5-18 state to "verify Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- calibration" by running controls. Review of the laboratory's 2017, 2018, and 2019 Coulter AcT diff calibration records revealed the records were incomplete: a. The calibration performed 10/11/17 was missing the post-calibration factors. b. The calibration performed 10/11/18 was missing the post-calibration factors and the calibration summary, and quality control material was tested prior to calibration. c. The calibration performed 5/1/19 was missing the calibrator assay sheet, the post- calibration factors, and the calibration summary, and quality control material was tested prior to calibration. During interview at approximately 1:20 p.m., the laboratory director stated that calibration is routinely performed by a service representative. She stated she was unaware some of the records were missing. -- 2 of 2 --